Note 2016:The MCIP site is no longer being updated and is maintained as an archive. For the latest on Vasalgel, please see Parsemus Foundation, and for updates on male contraception development and advocacy, please visit the dynamic new organization Male Contraception Initiative.

Gendarussa

This nonhormonal pill, derived from the plant Justicia gendarussa, could be the first new male contraceptive pill. Phase 2 clinical trials provide convincing evidence of its effectiveness, but will the Indonesian researchers get funding for their final clinical trials to get this product to market?

Antara News reported on August 18, 2013 that important research on Gendarussa had been completed by scientists at Airlangga University and the purified plant extract has been handed over to state pharmaceutical company Indofarma for stability testing and securing the production and distribution licenses. The process is expected to take less time because Gendarussa is considered a herbal medicine, and the pill may be available to Indonesians in a few years or possibly sooner if the testing progresses.

The latest news is that on Feb 12, 2014 a second MOU between Airlangga University, the National Family Planning Bureau and Indopharma was signed. It’s about the supply of materials, production and distribution rights and obligations. The first MOU signed in 2011 was about research issues. Indopharma is now beginning work on pilot scale production to determine Gendarussa product specifications, so that it can be registered as a new drug by the Indonesia FDA.

Research on the contraceptive properties of the Justicia gendarussa plant has been ongoing since 1985. The active ingredient was isolated and chemically synthesized, then manufactured into capsule form. The scientists heading up the research, Dr. Bambang Projogo and Dr. Dyan Pramesti, reported that phase two studies included 120 couples (80 given Gendarussa and 40 given placebo) for 108 days with no pregnancies. Additional studies were recently concluded in 350 couples (186 taking the capsule and 164 taking placebo) for 30 days with a reported success rate similar to that of oral contraceptives used by women.

While the Justicia gendarussa plant’s anti-inflammatory properties have been studied extensively, published information on its effects on male contraception is difficult to obtain. Scientists involved in the research report that the active ingredient in Gendarussa disrupts an enzyme in the sperm head, which weakens the ability of the sperm to penetrate the ovum. The effect is short term and reversible – having no effect on male hormones. The scientists even report increased libido in some patients.

Approval to use Gendarussa in countries outside Indonesia would to take longer, depending on how much of the Indonesian research meets those countries’ study protocols. To our knowledge, no Western organizations have teamed up with the Indonesian researchers, so an FDA approvals would have to start at the beginning and would most likely take 10+ years if successful at all. Since it is a herbal medicine, some propose a strategy of petitioning reputable herbal medicine companies (such as Jarrow, NOW Foods, or Nature Made) to make a high-quality (USP) version of it for Western use. And some are looking to help it get approved under the herbal drug regulatory system in Indonesia.

To move forward in Indonesia, funding is required for studies on the pharmacokinetics of the active compounds to determine more accurate duration of action, dosage and treatment periods, and to complete a larger challenge study. The researchers hope to be able to shorten the current treatment protocol of 20 days which is timed to the female menstrual cycle.

Results from clinical trials have not been published yet, but more information should be available shortly, as Dr. Pramesti won a travel award to attend the American Society of Andrology conference with Prof. Bambang. They presented data on Gendarussa results at the ASA meeting in Atlanta April 6, 2014. This visit was coordinated by Dr. David Sokal of the Foundation for Male Contraceptives, with support from Parsemus Foundation; kudos to Dr. Sokal for taking the initiative to make this crosscultural information exchange happen. Stay tuned for more information!